US FDA completes inspection of Alkem’s manufacturing facility in Indore
In response to Form 483 issued by the US FDA containing one observation, the company had submitted a detailed CAPA plan to the…
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Tag
USFDA
Zydus gets tentative nod from USFDA for Gabapentin Tablets, 300 mg and 600 mg
Gabapentin tablets are indicated for the management of Postherpetic Neuralgia (PHN)
Lupin receives EIR from US FDA for its injectable facility in Nagpur
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
US govt to procure 1.5 million more doses of Novavax COVID-19 vaccine
The protein-based vaccine was expected to convince those sceptical of the new mRNA-based vaccines against the virus from rivals…
Sun Pharma recalls 34000 bottles of Diltiazem Hydrochloride extended-release capsules from US
The capsules which are used to treat angina, high blood pressure and some types of irregular heartbeats failed dissolution testing
Lupin gets USFDA approval for Glycopyrrolate Injection, USP
The product marks the first approval from Lupin’s new injectable facility in Nagpur, India
FDA accepts NDA and grants priority review of Zuranolone from Sage Therapeutics, Biogen
Zuranolone is being evaluated as a potential 14-day, rapid-acting, once-daily, oral medication to treat major depressive disorder…
Fix quality issues, the rest will fall in place
As policymakers strive to link budgetary allocations to better quality compliance, with stricter oversight?
Stelis Biopharma’s facility receives EIR from USFDA
Establishment Inspection Report (EIR) from USFDA received for the drug-device combination to be commercialised from the company's…
USFDA pulls up Sun Pharma for lapses in Halol plant
In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces…